Vera Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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Sep 30, 2024 · Filed Nov 7, 2024
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Notes to Condensed Financial Statements
Notes to Unaudited Condensed Financial Statements
- ORGANIZATION AND DESCRIPTION OF THE BUSINESS
Description of Business
Vera Therapeutics, Inc. (the Company) is a clinical stage biotechnology company focused on developing and commercializing treatments for patients with serious immunological diseases. The Company was incorporated in May 2016 in Delaware. The Company’s headquarters and operations are located in Brisbane, California. The Company operates in one segment.
Liquidity
Since inception, the Company devoted substantially all of its resources to its research and development efforts, pre-clinical studies and clinical trials, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations. The Company has incurred recurring net operating losses and has not generated positive cash flow from operations since its inception and had an accumulated deficit of$417.8 million as of September 30, 2024. The Company had cash, cash equivalents and marketable securities of $353.3 million as of September 30, 2024. The Company has funded its operations primarily through the issuance of common stock, redeemable convertible preferred stock, debt financing and convertible notes. Management expects to continue to incur losses and negative cash flows from operations for at least the next several years.
Management believes that the Company’s cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months subsequent to the issuance date of these financial statements. The Company intends to raise additional capital through public or private equity offerings or debt financing or other capital sources, which may include strategic collaborations or other arrangements with third parties in order to achieve its long-term business objectives. If the Company fails to obtain necessary capital when needed on acceptable terms, or at all, it could force the Company to delay, limit, reduce or terminate its product development programs, commercialization efforts or other operations.
- BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (GAAP) and applicable rules and regulations of the Securities and Exchange Commission (the SEC) regarding interim financial reporting. The U.S. dollar is the Company’s functional and reporting currency.
Unaudited Condensed Financial Statements
In the opinion of management, the unaudited condensed financial statements reflect all adjustments of a normal recurring nature that are necessary for a fair presentation of the results for the periods presented. Interim results are not necessarily indicative of results for a full year or any other period. The information included in this Form 10-Q should be read in conjunction with the audited financial statements and related notes in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024.
Emerging Growth Company Status
The Company is an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012 (JOBS Act). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (1) is no longer an emerging growth company or (2) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
Use of Estimates
Thepreparation of the Company’s financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements and the reported amounts of expenses during the reporting period. Management estimates that affect the reported amountsof assets and liabilities include the accrual of research and development expenses, valuation of equity awards for stock-based compensation, determination of incremental borrowing rate for operating leases, the valuation allowance for deferred tax assets, and fair value of marketable and non-marketable securities. The Company evaluates and adjusts its estimates and assumptions on an ongoing basis using historical experience and other factors. Actual results could differ materially from those estimates.
Concentrations of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company maintains bank deposits in a federally insured financial institution and these deposits may exceed federally insured limits. The Company is exposed to credit risk in the event of default by the financial institution holding its cash, cash equivalents, and marketable securities to the extent recorded in the balance sheet. The Company has not experienced any losses to date related to these concentrations.
The Company’s future results of operations involve a number of other risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s current and potential future product candidates, uncertainty of market acceptance of the Company’s product candidates, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals or sole-source suppliers. The Company relies on one supply chain for each of its product candidates. If any of the single source suppliers in any of the supply chains fails to satisfy the Company’s requirements on a timely basis, it could suffer delays in its clinical development programs and activities, which could adversely affect operating results.
The Company’s product candidates require approvals from the U.S. Food and Drug Administration and comparable foreign regulatory authorities prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company was denied approval, approval was delayed, or the Company was unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company.
Significant Accounting Policies
There have been no material changes to the Company’s significant accounting policies from the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Recently Adopted Accounting Pronouncements
In June 2022, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard update clarifies the guidance in Topic 210, related to measuring the fair value of an equity security subject to contractual sale restrictions that prohibit the sale of an equity security and introduces new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. The guidance is effective for annual periods beginning after December 15, 2023, with early adoption permitted. The Company adopted this standard on January 1, 2024, and it did not have a material impact on the Company’s condensed financial statements or related disclosures.
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update improves reportable segment disclosure requirements and requires enhanced disclosures related to significant segment expenses regularly provided to the chief operating decision maker (CODM) and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Amendments in this update are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. This ASU will result in the required additional disclosures being included in the Company’s financial statements upon adoption.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The ASU requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as additional information on income taxes paid. The ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. Early adoption is also permitted for annual financial statements that have not yet been issued or made available for issuance. This ASU will result in the required additional disclosures being included in the Company’s financial statements upon adoption.
- OTHER FINANCIAL STATEMENT INFORMATION
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following (in thousands):
| September 30,2024 | December 31,2023 | |
|---|---|---|
| Prepaid clinical trial costs | $3,825 | $5,273 |
| Interest income receivable | 1,997 | 512 |
| Prepaid insurance | 988 | 597 |
| Prepaid medical affairs expenses | 820 | — |
| Prepaid commercial planning | 597 | 789 |
| Prepaid professional services fees | 432 | 198 |
| Prepaid drug manufacturing costs | 411 | 2,578 |
| Prepaid software license fees | 349 | 237 |
| Prepaid rent | 274 | 257 |
| Other | 1,129 | 866 |
| Total prepaid expenses and other current assets | $10,822 | $11,307 |
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following (in thousands):
| September 30,2024 | December 31,2023 | |
|---|---|---|
| Accrued clinical trial and drug manufacturing expenses | $14,529 | $2,213 |
| Accrued payroll | 3,641 | 3,932 |
| Related party payable | 105 | 1,926 |
| Other accrued expenses | 1,429 | 678 |
| Other current liabilities | 286 | — |
| Total accrued expenses and other current liabilities | $19,990 | $8,749 |
Related party payable represents amounts due to Ares Trading S.A. (Ares), an affiliate of Merck KGaA, Darmstadt, Germany, related to manufacturing technology and know-how transfer services performed for atacicept pursuant to the license agreement between the Company and Ares (see Note 10).
- CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES
The Company’s cash equivalents and available-for-sale investment securities are classified within the fair value hierarchy as defined by authoritative guidance. Level 1 securities consist of highly liquid money market funds for which the carrying amount approximates the fair value of identical assets as quoted in the active markets. Level 2 securities, consisting of U.S. Treasuries, U.S. agency securities and corporate debt securities, are measured based on other observable inputs, including broker or dealer quotations or other valuations using observable market data. The Company’s debt securities are accounted for as available-for-sale securities.
Unrealized gains and losses are reported as a component of other comprehensive income (loss). Fair value of the debt securities was $326.1 million and $115.0 million as of September 30, 2024 and December 31, 2023, respectively.
The following table presents the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):
| Fair Value Hierarchy Level · Amortized Cost · Unrealized Gains · Unrealized Losses · Estimated Fair Value · Cash and Cash Equivalents · Marketable Securities | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Money market funds | Level 1 | $24,814 | $ | - | $ | - | $24,814 | $24,814 | $ | - | |
| U.S. Government bonds | Level 2 | 186,687 | 601 | - | 187,288 | - | 187,288 | ||||
| U.S. Government agency securities | Level 2 | 5,996 | 3 | - | 5,999 | - | 5,999 | ||||
| Corporate debt securities | Level 2 | 132,326 | 440 | - | 132,766 | - | 132,766 | ||||
| Total cash equivalents and marketable securities | 349,823 | 1,044 | - | 350,867 | 24,814 | 326,053 | |||||
| Cash | 2,442 | ||||||||||
| Total | $349,823 | $1,044 | $ | - | $350,867 | $27,256 | $326,053 | ||||
| Fair Value Hierarchy Level · Amortized Cost · Unrealized Gains · Unrealized Losses · Estimated Fair Value · Cash and Cash Equivalents · Marketable Securities | |||||||||||
| Money market funds | Level 1 | $44,650 | $ | - | $ | - | $44,650 | $44,650 | $ | - | |
| U.S. Government bonds | Level 2 | 63,619 | 70 | (6) | 63,683 | - | 63,683 | ||||
| U.S. Government agency securities | Level 2 | 19,665 | 7 | (14) | 19,658 | - | 19,658 | ||||
| Corporate debt securities | Level 2 | 31,500 | 194 | - | 31,694 | - | 31,694 | ||||
| Total cash equivalents and marketable securities | 159,434 | 271 | (20) | 159,685 | 44,650 | 115,035 | |||||
| Cash | 1,031 | ||||||||||
| Total | $159,434 | $271 | $(20) | $159,685 | $45,681 | $115,035 | |||||
Marketable debt securities that had been in unrealized loss positions as of September 30, 2024, and December 31, 2023, were in an unrealized loss position for less than 12 months. Unrealized losses from marketable debt securities are primarily attributable to changes in interest rates. Management does not believe any remaining unrealized losses represent impairments based on evaluation of available evidence.
The following table classifies the estimated fair value of investments in available-for-sale marketable debt securities by effective contractual maturity dates (in thousands):
| Due within one year | $292,827 |
|---|---|
| Due after one year to two years | 33,226 |
| Total marketable securities | $326,053 |
- LEASES
The Company has entered into non-cancellable operating leases, including a sublease entered into in August 2024 for an office facility in Brisbane, California, that will serve as its corporate headquarters as of November 2024. This sublease expires in 2029. The lease for the Company’s current corporate headquarters expires in November 2024. The Company also leases a facility in South San Francisco, California, that is subleased under a non-cancellable agreement to a third party, which ends concurrently with the original lease in September 2025.
Net lease cost is as follows(in thousands):
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Operating lease cost | $669 | $644 | $1,940 | $1,933 |
| Sublease income | (487) | (482) | (1,462) | (1,446) |
| Net lease cost | $182 | $162 | $478 | $487 |
As of September 30, 2024, under the terms of the sublease agreement of the South San Francisco facility to a third party, the Company is entitled to receive future annual sublease payments as follows (in thousands):
| 2024 (remaining) | 491 |
| 2025 | 1,496 |
| Total sublease payments | $1,987 |
As tenant under the South San Francisco facility lease, the Company remains responsible for minimum lease commitments of $2.5 million as of September 30, 2024.
As of September 30, 2024, the future undiscounted lease payments under operating leases recognized in the condensed financial statements was $6.1 million. The weighted-average remaining lease term was 3.0 years and the weighted-average discount rate was 9.1%. As of September 30, 2024, the Company had not executed any leases that were yet to commence.
- NOTES PAYABLE
Notes payable consist of the following (in thousands):
| September 30, 2024 · December 31, 2023 | |||||
|---|---|---|---|---|---|
| Maturity | EffectiveInterest Rate | Amount | Effective Interest Rate | Amount | |
| Collateralized note 2021-12 | 2027 | 14.59% | $5,000 | 14.73% | $5,000 |
| Collateralized note 2022-11 | 2027 | 14.73% | 20,000 | 14.87% | 20,000 |
| Collateralized note 2023-12 | 2027 | 15.23% | 25,000 | 15.37% | 25,000 |
| Total borrowings | 50,000 | 50,000 | |||
| Accrued exit fee net of unamortized issuance costs | 470 | (123) | |||
| Net carrying amount of debt | $50,470 | $49,877 | |||
The carrying amount of debt approximates fair value due to its variable interest rate.
In December 2021, the Company entered into a non-revolving loan and security agreement (the Loan Agreement) with Oxford Finance. The Loan Agreement has a borrowing capacity of up to $50.0 million, of which $5.0 million was funded in December 2021, with the remaining credit facility available for draw until December 2022, with maturity of the outstanding balance in December 2026. In November 2022, the Company entered into an amendment of the Loan Agreement. Among other changes, the amendment extended the scheduled expiration of the Loan Agreement from December 2022 to December 2023 and modified the reference rate from the London Interbank Offered Rate (LIBOR) to the Secured Overnight Financing Rate (SOFR). In conjunction with the amendment, the Company borrowed an additional $20.0 million under the Loan Agreement. In December 2023, the Company borrowed the remaining $25.0 million under the Loan Agreement. As of September 30, 2024, the Company’s outstanding borrowing under the Loan Agreement was $50.0 million.
In March 2023, upon achievement of a clinical data milestone, the Company elected to exercise a borrower option to extend the maturity of the outstanding loan by 12 months, from December 2026 to December 2027. The end date of the interest-only payment period was also extended by 12 months, from December 2025 to December 2026. The Company is permitted to prepay the loan, subject to certain conditions. Upon the maturity date or prepayment of the loan, the Company is required to pay an exit fee equal to 7% of the aggregate principal amount of the loan.
The variable interest rate on the drawn amount is adjusted SOFR plus 825 basis points, subject to a per annum floor rate of 8.25%. The Loan Agreement contains a subjective acceleration clause in the case of an event of default. If such a matter occurs and is continuing, the lender may legally demand the outstanding principal and interest immediately due and payable. There are no financial covenants associated with the Loan Agreement and the loan is secured by the Company’s assets. The Loan Agreement is available for working capital, capital expenditures, and other general corporate purposes.
Principal installments due on the notes are as follows (in thousands):
| Remainder of 2024 | — |
| 2025 | — |
| 2026 | — |
| 2027 | 50,000 |
| Total long-term debt | $50,000 |
- COMMON STOCK
As of September 30, 2024, the Company’s amended and restated certificate of incorporation authorized the Company to issue 500,000,000 shares of Class A common stock and 14,600,000 shares of Class B common stock, each with a par value of $0.001 per share. Each share of Class A common stock entitles the holder toone vote on all matters submitted to a vote of the Company’s stockholders. Class B common stock is non-voting. There areno shares of Class B common stock outstanding as of September 30, 2024. Common stockholders are entitled to receive dividends, as may be declared by the board of directors. Through September 30, 2024, no cash dividends have been declared or paid.
In June 2022, the Company filed a shelf registration statement on Form S-3 (File No. 333-265408) with the Securities and Exchange Commission, which permits the offering, issuance, and sale of up to a maximum aggregate offering price of $400.0 million of the Company’s common stock, preferred stock, debt securities and warrants. Up to a maximum of $150.0 million of the maximum aggregate offering price of $400.0 million may be issued and sold pursuant to an at-the-market financing facility under a sales agreement dated June 3, 2022, between the Company and Cowen and Company, LLC (Sales Agreement). In January 2024, the Company suspended and terminated the prospectus (the ATM Prospectus) related to the sale of its Class A common stock in an “at-the-market” offering pursuant to the terms of the Sales Agreement. As a result, the Company will not make any sales of its Common Stock pursuant to the Sales Agreement unless and until a new prospectus, prospectus supplement or registration statement is filed. Deferred costs of $0.3 million were recognized as general and administrative expense upon termination of the ATM Prospectus.
In February 2023, the Company completed a follow-on public offering pursuant to which the Company issued and sold 16,428,572 shares of its Class A common stock at a public offering price of $7.00 per share, including 2,142,857 shares of Class A common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares.
In February 2024, the Company completed a follow-on public offering pursuant to which the Company issued and sold 9,274,194 shares of its Class A common stock at a public offering price of $31.00 per share, including 1,209,677 shares of Class A common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares.
- STOCK COMPENSATION
The 2021 Employee Stock Purchase Plan (ESPP) and the 2021 Equity Incentive Plan (2021 EIP) became effective in May 2021. The Company has reserved 1,152,463 and 6,873,404 shares of Class A common stock for issuance under the ESPP and 2021 EIP, respectively.
The Company may not grant any additional awards under the 2017 Equity Incentive Plan (2017 EIP). The 2017 EIP will continue to govern outstanding equity awards granted thereunder. As of September 30, 2024, there were 677,465 shares available for issuance under the 2021 EIP.
In August 2024, the Company repurchased 4,450 unvested shares that were previously outstanding due to a stock option that was early exercised. The unvested shares were repurchased at the original exercise price of $2.8968 per share.
2017 EIP and 2021 EIP
Stock option activity under the 2017 EIP and 2021 EIP was as follows:
| Number of Options | Weighted Average Exercise Price per Share | Weighted Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value (000s) | |
|---|---|---|---|---|
| Outstanding as of December 31, 2023 | 5,762,236 | $9.42 | 7.66 | $39,197 |
| Granted | 2,340,950 | |||
| Exercised | (1,167,790) | |||
| Cancelled and forfeited | (445,937) | |||
| Outstanding as of September 30, 2024 | 6,489,459 | $13.97 | 8.16 | $196,198 |
| Options exercisable as of September 30, 2024 | 2,646,618 | $9.14 | 7.23 | $92,781 |
| Vested and expected to vest as of September 30, 2024 | 6,489,459 | $13.97 | 8.16 | $196,198 |
The aggregate intrinsic value of stock options exercised during the three and nine months ended September 30, 2024, was approximately $3.5 and $34.7 million, respectively. The weighted average grant date fair value of options granted during the three and nine months ended September 30, 2024 was $26.35 and $15.91 per share, respectively.
ESPP
The ESPP enables eligible employees to purchase shares of the Company’s common stock at the end of each offering period at a price equal to 85% of the fair market value of the shares on the first trading day or the last trading day of the offering period, whichever is lower. Eligible employees generally include all employees. Share purchases are funded through payroll deductions of at least 1% and up to 15% of an employee’s eligible compensation for each payroll period. The number of shares reserved for issuance under the ESPP increases automatically on the first day of each fiscal year, beginning on January 1, 2022, by a number equal to the lesser of 440,502 shares,1% of the total number of shares of the Company’s capital stock (including all classes of the Company’s common stock) outstanding on the last day of the calendar month prior to the date of the increase, or such lower number of shares (including no shares) approved by the Company’s board of directors. As of September 30, 2024, 88,752 shares have been issued pursuant to the ESPP. The ESPP generally provides for six-month consecutive offering periods beginning on September 14, 2021. The ESPP is a compensatory plan as defined by the authoritative guidance for stock compensation. Stock-based compensation expense related to the ESPP for the three and nine months ended September 30, 2024, was $0.1 million and $0.2 million, respectively.
Stock-Based Compensation Expense
The following tables summarize the stock-based compensation expense for stock options and restricted stock units granted to employees and nonemployees and for ESPP stock-based compensation that was recorded in the Company’s condensed statements of operations and comprehensive loss for thethree and nine months ended September 30, 2024 and 2023.
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Research and development | $2,261 | $1,146 | $5,888 | $3,511 |
| General and administrative | 3,327 | 1,777 | 8,697 | 4,761 |
| Total stock-based compensation expense | $5,588 | $2,923 | $14,585 | $8,272 |
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Employees | $4,791 | $2,621 | $12,923 | $7,542 |
| Nonemployees | 797 | 302 | 1,662 | 730 |
| Total stock-based compensation expense | $5,588 | $2,923 | $14,585 | $8,272 |
As of September 30, 2024, the Company had $41.3 million of unrecognized stock-based compensation expense related to unvested stock options, which is expected to be recognized over a weighted-average period of approximately 2.7 years.
The fair value of stock options granted during thethree and nine months ended September 30, 2024 and 2023, was estimated using the Black-Scholes option pricing model based on the following weighted-average assumptions.
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Expected term (in years) | 6 - 6.1 | 6.1 | 5.5 - 6.1 | 5.5 - 6.1 |
| Expected volatility | 70.3% - 70.4% | 80.2% | 70.3% - 73.2% | 79.5% - 80.5% |
| Risk-free rate | 3.6% - 4.4% | 4.2% | 3.6% - 4.6% | 3.4% - 4.2% |
| Dividend yield | — | — | — | — |
Restricted Stock Units
The Company grants restricted stock units (RSU) pursuant to the 2021 EIP and satisfies such grants through the issuance of its common stock. The following table shows RSU activity for the period ended September 30, 2024.
| Number of Shares | Weighted Average Grant Date Fair Value per Share | |
|---|---|---|
| Unvested balance at December 31, 2023 | 131,679 | $18.36 |
| Granted | 484,662 | 22.07 |
| Vested | (107,472) | 18.52 |
| Cancelled and forfeited | (29,332) | 17.86 |
| Unvested balance at September 30, 2024 | 479,537 | $22.10 |
For the nine months ended September 30, 2024, the Company recognized $2.5 millionof stock-based compensation for restricted stock units.
As of September 30, 2024, the Company had $9.3 million of unrecognized stock-based compensation expense related to unvested RSUs, which is expected to be recognized over a weighted-average period of approximately 3.5 years.
Inducement Plan
In February 2024, the Company adopted the 2024 Inducement Plan (Inducement Plan). The Inducement Plan was adopted by the compensation committee of the Company’s board of directors without stockholder approval pursuant to Nasdaq Marketplace Rule 5635(c)(4). In accordance with Rule 5635(c)(4), awards made under the Inducement Plan, including stock options and restricted stock units, may only be granted to newly hired employees as a material inducement to accept employment with the Company. Awards granted under the Inducement Plan expire no later thanten years from the date of grant. An aggregate of 1,250,000 shares of common stock were reserved for issuance under the Inducement Plan. As of September 30, 2024, there were 738,025 shares available for issuance under the Inducement Plan.
- EMPLOYEE BENEFIT PLANS
The Company sponsors a qualified 401(k) defined contribution plan covering eligible employees. Participants may contribute a portion of their annual compensation limited to a maximum annual amount set by the Internal Revenue Service. The Company contributed $29,000 and $12,000 to the plan for the three months ended September 30, 2024 and 2023, respectively, and $180,000 and$138,000 for the nine months ended September 30, 2024 and 2023, respectively.
- LICENSES AND COLLABORATIONS
Ares Trading S.A.
In October 2020, the Company entered into a license agreement with Ares (the Ares Agreement), pursuant to which the Company obtained an exclusive worldwide license to certain patents and related know-how to research, develop, manufacture, use and commercialize therapeutic products containing atacicept, a recombinant fusion protein used to inhibit B cell growth and differentiation, which could potentially treat some autoimmune diseases.
As consideration for the Ares Agreement, the Company paid a non-refundable license issue fee to Ares in the form of shares of redeemable convertible preferred stock valued at $13.1 million, resulting in Ares becoming a related party to the Company. The redeemable convertible preferred stock subsequently converted into 1,913,501 shares of Class A common stock in May 2021.
In December 2020, the Company paid Ares a milestone payment of $25.0 million upon delivery and initiation of the transfer of specified information and materials. The non-refundable license issue fee and milestone payment were recorded to research and development expense in the period incurred. The Company is obligated to pay Ares aggregate milestone payments of up to $176.5 million upon the achievement of specified BLA filing or regulatory approval milestones, beginning with $15.0 million upon the first filing of an approval application and $20.0 million upon regulatory approval in the U.S., and up to $515.0 million upon the achievement of specified commercial milestones, beginning with $15.0 million if worldwide aggregate annual net sales reach $250 million and $50.0 million if worldwide aggregate annual net sales reach $500 million.
Subsequent to the effective date of the Ares Agreement, Ares is performing manufacturing technology and know-how transfer to the Company. The Company recorded related party expense of $0.1 million and $0.4 million to Ares for these services during the three months ended September 30, 2024 and 2023, respectively, and $0.3 million and$2.4 million during the nine months ended September 30, 2024 and 2023, respectively. These amounts are included in research and development expenses on the statements of operations and comprehensive loss.
Commencing on the first commercial sale of licensed products, the Company is obligated to pay Ares tiered royalties of low double-digit to mid-teen percentages on annual net sales of the licensed products covered by the license. The Company is obligated to pay royalties on a licensed product-by-licensed product and country-by-country basis from the first commercial sale of a product in a country until the latest of (i) 15 years after the first commercial sale of such licensed product in such country; (ii) the expiration of the last valid claim of a licensed patent that covers such licensed product in, or its use, importation or manufacture with respect to, such country; and (iii) expiration of all applicable regulatory exclusivity periods, including data exclusivity, in such country with respect to such product. If the Company were to sublicense its rights under the Ares Agreement, the Company would be obligated to pay Ares a percentage ranging from the mid-single-digit to the low double-digits of specified sublicensing income received.
Amplyx Pharmaceuticals, Inc.
In December 2021, the Company entered into an asset purchase agreement (the Amplyx Agreement) with Amplyx Pharmaceuticals, Inc. (Amplyx), a wholly owned subsidiary of Pfizer Inc. Pursuant to the terms of the Amplyx Agreement, the Company paid $5.0 million to Amplyx to purchase assets relating to an anti-BKV monoclonal antibody referred to as MAU868 for the treatment of BKV infection pursuant to a License Agreement between Amplyx and Novartis International Pharmaceutical AG (Novartis). In addition, the Company recognized a $2.0 million contingent milestone obligation as an assumed liability related to the asset purchase. The acquisition cost of $7.0 million was recorded as research and development expense in the statement of operations and comprehensive loss on the acquisition date.
In connection with the Amplyx asset purchase, Amplyx assigned the Exclusive License Agreement between Amplyx and Novartis (the Novartis License) and Manufacturing and Supply Agreements to the Company. Under the Novartis License, the Company has exclusive worldwide rights from Novartis to develop, manufacture and commercialize MAU868. The Company will be solely responsible for all research, development, regulatory, manufacturing and commercialization activities of MAU868.
Under the Amplyx Agreement, the Company is obligated to make future milestone payments to Amplyx and Novartis upon the achievement of specified development, regulatory and commercial milestones. In September 2022, the Company and Novartis entered into an amendment to the Novartis License to modify the terms of future milestone payments. Pursuant to this amendment, the Company issued 283,034 shares of Class A common stock to Novartis in exchange for a reduction of $7.0 million in contingent future development milestones, including the $2.0 million contingent milestone obligation accrued by the Company in December 2021. The value of the shares issued was $5.7 million based on the closing market value of the Company’s Class A common stock as of the effective date of the amendment.
The Company is obligated to make future milestone payments of up to $7.0 million and $62.0 million to Amplyx and Novartis, respectively, contingent upon the achievement of specified development, regulatory and commercial milestones. In the event that MAU868 is commercialized, the Company will be obligated to pay royalties to Amplyx and Novartis based on net sales by country and by product.
- COMMITMENTS AND CONTINGENCIES
Legal Proceedings
The Company believes that there are no actions pending which would have a material adverse effect on its results of operations, financial condition, or cash flows.
Indemnifications
As of September 30, 2024, the Company did not have any material indemnification claims that were probable or reasonably possible, and consequently no related liabilities have been recorded.
Employee Agreements
The Company has signed employment agreements with certain key employees pursuant to which, if their employment is terminated following a change of control of the Company, the employees are entitled to receive certain benefits, including severance and accelerated vesting of equity incentives.
Development and Manufacturing Services Agreements
The Company enters into development and manufacturing contracts with vendors in the conduct of our business. Contracts with these vendors may be terminated at the Company’s option, with varying provisions regarding termination. If a contract with a specific vendor were to be terminated, the Company would be obligated to pay for the products or services that had been provided or received at the time the termination became effective, and potentially additional compensation based upon the period of time remaining between the date of notice of cancellation and the scheduled manufacturing.
- NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS
The following outstanding potentially dilutive shares were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented, because including them would have been anti-dilutive (on an as-converted basis).
| Three Months EndedSeptember 30, | Nine Months EndedSeptember 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Class A common stock options issued and outstanding | 6,489,459 | 5,732,181 | 6,489,459 | 5,732,181 |
| Unvested RSUs | 479,537 | 132,616 | 479,537 | 132,616 |
| Total | 6,968,996 | 5,864,797 | 6,968,996 | 5,864,797 |
- RELATED PARTY TRANSACTIONS
In October 2020, the Company entered into the Ares Agreement with Ares, pursuant to which the Company obtained an exclusive worldwide license to certain patents and related know-how to research, develop, manufacture, use and commercialize therapeutic products containing atacicept, a recombinant fusion protein used to inhibit B cell growth and differentiation, which could potentially treat some autoimmune diseases. Related party transactions and balances in the current periods presented are described in Note 3 and Note 10.
Sofinnova Venture Partners X, L.P. (SVP X) is an investment fund in which Maha Katabi (Dr. Katabi), a member of the Company’s board of directors, has a pecuniary interest. SVP X completed transactions in the Company’s common stock within a six-month period ended March 25, 2024. The transactions included both purchases and sales of shares of the Company’s common stock that may be matchable for purposes of Section 16(b) of the Securities Exchange Act of 1934, as amended. These transactions could be deemed to have resulted in short-swing profits to Dr. Katabi of $36,620. Dr. Katabi voluntarily agreed to disgorge the profits and has paid $36,620 to the Company as a result of these transactions.
- SUBSEQUENT EVENT
On October 31, 2024, the Company completed a follow-on public offering pursuant to which the Company issued and sold 7,142,858 shares of its common stock at an offering price of $42.00 per share. On November 5, 2024, the Company issued an additional 1,071,428 shares of common stock at $42.00 per share, pursuant to the underwriters’ option. The Company received aggregate net proceeds of approximately $323.6 million, after deducting underwriting discounts and commissions of $20.7 million, and offering costs of approximately $0.7 million.
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